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An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2) (NEAR-2)

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CSF-1
Vehicle
Sponsored by
Orasis Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have presbyopia.

Exclusion Criteria:

Subjects must not:

  • Have any contraindications to the study medications or diagnoses that would confound the study.

Sites / Locations

  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site
  • Orasis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CSF-1

Vehicle

Arm Description

One drop bilaterally twice daily for approximately 2 weeks.

One drop bilaterally twice daily for approximately 2 weeks.

Outcomes

Primary Outcome Measures

Percentage of subjects with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.

Secondary Outcome Measures

Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m.

Full Information

First Posted
October 19, 2020
Last Updated
January 8, 2023
Sponsor
Orasis Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04599972
Brief Title
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
Acronym
NEAR-2
Official Title
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orasis Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSF-1
Arm Type
Experimental
Arm Description
One drop bilaterally twice daily for approximately 2 weeks.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop bilaterally twice daily for approximately 2 weeks.
Intervention Type
Drug
Intervention Name(s)
CSF-1
Other Intervention Name(s)
pilocarpine HCl 0.4%
Intervention Description
One drop bilaterally twice daily for approximately 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
One drop bilaterally twice daily for approximately 2 weeks.
Primary Outcome Measure Information:
Title
Percentage of subjects with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Percentage of subjects with a ≥ 3-line gain in BDCVA at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
Time Frame
Day 1/Day 8/Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have presbyopia. Exclusion Criteria: Subjects must not: Have any contraindications to the study medications or diagnoses that would confound the study.
Facility Information:
Facility Name
Orasis Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Orasis Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Orasis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Orasis Investigative Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Orasis Investigative Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Orasis Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Orasis Investigative Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Orasis Investigative Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Orasis Investigative Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Orasis Investigative Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Orasis Investigative Site
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Orasis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Orasis Investigative Site
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Orasis Investigative Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Orasis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Orasis Investigative Site
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Orasis Investigative Site
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Orasis Investigative Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)

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